Packaging and storage—
Preserve in tight containers, at controlled room temperature, and protect from freezing.
Labeling—
Label it to indicate that it is for single-dose intraocular use only, and that the unused portion is to be discarded.
Identification—
Dilute, if necessary, an accurately measured volume of Intraocular Solution quantitatively and stepwise with water to obtain a solution containing about 100 µg of carbachol per mL. Transfer 5 mL of this test solution to a 125-mL separator. To another separator, add 5 mL of water to provide a blank. To each separator add 1.0 mL of 1 N sodium hydroxide and 2.0 mL of a 2 in 1000 solution of hexanitrodiphenylamine in 0.1 N sodium hydroxide. Mix, add 15 mL of methylene chloride to each separator, shake for 1 minute, and allow the layers to separate: a deep amber color is produced in the methylene chloride layer obtained from the test solution.
Assay—
Assay preparation—
Dilute, if necessary, an accurately measured volume of Intraocular Solution quantitatively and stepwise with water to obtain a solution containing about 100 µg of carbachol per mL.
71
:
meets the requirements.